Surveillance Program to Determine Product Specific Rates of Invasive Hib Disease

Study at a glance

From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

Surveillance for Rates of Hib Disease Among Persons 0 Through 59 Months of Age Receiving Pentacel® or Other Hib Vaccines

ClinicalTrials.gov ID

NCT00855855

Acronym / sponsor ID

M5A15

Conditions

Haemophilus Infections, Diphtheria, Tetanus, Polio, Pertussis

Keywords

Diphtheria, Tetanus, Pertussis, Poliovirus types 1-3, Haemophilus influenzae type b, Pentacel®

Study type

Observational

Recruitment status

Completed

Enrolment

20,830 participants (actual)

Lead sponsor

Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)

Study start

Feb 2009 (actual)

Primary completion

Dec 2014 (actual)

Study completion

Dec 2014 (actual)

First posted

4 Mar 2009 (estimated)

Results

Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model

Cohort

Time perspective

Cross-sectional

Number of arms

1

Who may qualify

Ages

Up to 59 months

Sex

All

Healthy volunteers

Accepted

Age groups

Child

Study population

5.2 million person years over the 6 year study period

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. The rate of invasive Hib disease among persons within the population monitored by the Active Bacterial Core surveillance program.

   Time frame: Up to 6 years post vaccination

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
• Related InfoLink provided by the sponsor.
• Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

59 sites in 1 country: see every site and its status.